Glatiramer acetate (GA), the active ingredient of Copaxone®, consists of the acetate salts of synthetic polypeptides, containing four naturally occurring amino acids: L-glutamic acid, L-alanine, L-tyrosine, and L-lysine with an average molar fraction of 0.141, 0.427, 0.095, and 0.338, respectively. The peak average molecular weight of glatiramer acetate is between 5,000 and 9,000 daltons. Glatiramer acetate is identified by specific antibodies (Copaxone, Food and Drug Administration Approved Labeling (Reference ID: 3443331) [online], TEVA Pharmaceutical Industries Ltd., 2014 [retrieved on Dec. 24, 2014], Retrieved from the Internet: <URL: www.accessdata.fda.gov/drugsatfda_docs/label/2014/020622s0891bl.pdf>).
Chemically, glatiramer acetate is designated L-glutamic acid polymer with L-alanine, L-lysine and L-tyrosine, acetate (salt). Its structural formula is:(Glu,Ala,Lys,Tyr)x.X CH3COOH(C5H9NO4.C3H7NO2.C6H14N2O2.C9H11NO3).xC2H4O2 
CAS-147245-92-9
Copaxone® is a clear, colorless to slightly yellow, sterile, nonpyrogenic solution for subcutaneous injection. Each 1 mL of Copaxone® solution contains 20 mg or 40 mg of GA, the active ingredient, and 40 mg of mannitol. The pH of the solutions is approximately 5.5 to 7.0. Copaxone® 20 mg/mL in a prefilled syringe (PFS) is an approved product, the safety and efficacy of which are supported by over two decades of clinical research and over a decade of post-marketing experience. Copaxone® 40 mg/mL in a PFS was developed as a new formulation of the active ingredient GA. Copaxone® 40 mg/mL is a prescription medicine used for the treatment of people with relapsing forms of multiple sclerosis (Copaxone, Food and Drug Administration Approved Labeling (Reference ID: 3443331) (online), TEVA Pharmaceutical Industries Ltd., 2014 [retrieved on Dec. 24, 2014], Retrieved from the Internet: <URL: www.accessdata.fda.gov/drugsatfda_docs/label/2014/020622s0891bl.pdf>).
It is an object of the present invention to provide an improved process for manufacturing GA drug products.